MAUDE Adverse Event Report: BD CARIBE LTD. BD BLOOD TRANSFER DEVICE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	36488000
Medical Device Problem Codes	Short Fill (1575); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use with bd blood transfer device the tube was unable to fill fully and the sleeve separated.The following information was provided by the initial reporter, translated from japanese to english: the customer reported that blood was dispensed into two blood collection tubes.The first tube was able to dispense blood normally, but blood did not flow into the second tube.Since the blood had not clotted in the syringe, an attempt was made to dispense it again, but no blood flowed in.When the blood collection tube was removed from the btd, the rubber sleeve came off along with the blood collection tube.The blood collection tube to which it was dispensed has already been discarded.The patient is htlv positive.
Additional Manufacturer Narrative
H.6 investigation summary: bd received 1 sample for investigation.The sample was evaluated by visual examination and the indicated failure mode for sleeve fall off with the incident lot was observed.Due to the sample being used it could not be evaluated for insufficient flow.Additionally, 48 retention samples from bd inventory were evaluated by visual examination, and another 12 retention samples by functional draw testing, and the issues of sleeve fall off and insufficient flow were not observed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode sleeve fall off.This complaint could not be confirmed for insufficient blood flow.Bd was not able to identify a root cause for the indicated failure modes.

• Brand Name: BD BLOOD TRANSFER DEVICE
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17999443
• Report Number: 2618282-2023-00091
• Device Sequence Number: 12432612
• Product Code: JKA
• UDI-Device Identifier: 50382903648806
• UDI-Public: (01)50382903648806
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: 36488000
• Device Lot Number: 2353695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown